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Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy

U

Universidad de Murcia

Status

Completed

Conditions

Cerebral Palsy

Treatments

Other: Physical Therapy
Device: Assisted gait training with Walkbot System

Study type

Interventional

Funder types

Other

Identifiers

NCT04329793
2365/2019

Details and patient eligibility

About

The improvement of walking capacity is a key objective of the rehabilitation of children with PC. There are different approaches from physiotherapy to address this need, including walking on the ground and on treadmill with partial weight support. Currently, there are robotic technologies adapted to the functional rehabilitation of patients. Assisted gait training with robotic devices such as the Walkbot allows a longer duration of training, at more variable speeds, and with a constant gait pattern adapted to the patient. This training, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions.

There are some studies that evaluate walking interventions on treadmill with partial weight support, on the ground and in assisted walking robot in patients with PC.

Currently, there are no studies conducted that report the effectiveness of interventions performed with robotic walking training device Walkbot K on PC. However, studies in adults with Walkbot S, affected with neurological injury, have reported good results.

Assisted gait training with robotic devices such as the Walkbot, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions. However, due to the little evidence that exists, it is necessary to know the effectiveness of the Walkbot assisted walking robot in these patients by means of a clinical trial that allows to firmly establish the scope of its benefits.

Enrollment

23 patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cerebral palsy diagnosis (diplegia or tetraplegia)
  • Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)
  • Levels II, III and IV in GMFCS
  • Unsupported seating capacity
  • Go on standing with or without help
  • Not receiving therapy with a walking robot and not having received it in at least one year

Exclusion criteria

  • Serious psychiatric problems
  • Serious heart problems
  • Active tumors
  • Severe joint degenerative problems
  • Degenerative diseases of the nervous system
  • Mitochondrial diseases
  • Recent surgeries
  • Unbound fractures
  • Severe osteoporosis
  • Uncontrolled seizures
  • Open wounds in the lower half of the body
  • Extreme fear of being placed in robotic devices
  • Anthropomorphic measures are below the minimum required to use the device

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Intervention arm
Experimental group
Description:
Assisted gait training with Walkbot System and their usual Physical Therapy.
Treatment:
Other: Physical Therapy
Device: Assisted gait training with Walkbot System
Control arm
Active Comparator group
Description:
Their usual Physical Therapy.
Treatment:
Other: Physical Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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